FDA.report

Application 084427

Type
ANDA
Sponsor
PFIZER

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DILANTINPHENYTOINTABLET, CHEWABLE;ORAL50MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0071-0007Dilantin InfatabsPhenytoinParke-Davis Div of Pfizer IncANDACurrent
0071-0007Dilantin InfatabsPhenytoinParke-Davis Div of Pfizer IncANDACurrent
0071-0007Dilantin InfatabsPhenytoinParke-Davis Div of Pfizer IncANDACurrent
0071-0007Dilantin InfatabsPhenytoinParke-Davis Div of Pfizer IncANDACurrent
0071-0007Dilantin InfatabsPhenytoinParke-Davis Div of Pfizer IncANDACurrent
0615-8260Phenytoin InfatabsPhenytoinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8260Phenytoin InfatabsPhenytoinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8260Phenytoin InfatabsPhenytoinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8424Phenytoin InfatabsPhenytoinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
59762-5210Phenytoin InfatabsPhenytoinGreenstone LLCANDACurrent
59762-5210Phenytoin InfatabsPhenytoinGreenstone LLCANDACurrent
59762-5210Phenytoin InfatabsPhenytoinGreenstone LLCANDACurrent
59762-5210Phenytoin InfatabsPhenytoinGreenstone LLCANDACurrent
66993-372Phenytoin InfatabsPhenytoinPrasco LaboratoriesANDACurrent
66993-372Phenytoin InfatabsPhenytoinPrasco LaboratoriesANDACurrent

Documents

DocumentSubmission typeDate
58057SUPPL2019-03-21
56342SUPPL2018-11-08
50998SUPPL2018-01-08
50997SUPPL2018-01-08
50996SUPPL2018-01-08
48068SUPPL2017-04-19
39586SUPPL2015-04-23
9242SUPPL2015-04-23
18503SUPPL2014-07-29
39585SUPPL2014-03-11
39584SUPPL2014-03-11
39583SUPPL2014-03-11
39582SUPPL2014-03-11
18502SUPPL2013-09-19
31430SUPPL2013-08-08
31429SUPPL2012-12-06
18501SUPPL2012-11-30
18500SUPPL2011-05-06
18499SUPPL2009-10-19
22663ORIG2005-07-22